Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study

Vincent Puel, Isabelle Godard, Georgios Papaioannou, Philippe Gosse, Jean Louis Pepin, Fabrice Thoin, Jean Claude Deharo, Frederic Roche, Naïma Zarqane, Frédéric Gagnadoux, Carey Meredith Suehs, Nicolas Molinari, Vincent Puel, Isabelle Godard, Georgios Papaioannou, Philippe Gosse, Jean Louis Pepin, Fabrice Thoin, Jean Claude Deharo, Frederic Roche, Naïma Zarqane, Frédéric Gagnadoux, Carey Meredith Suehs, Nicolas Molinari

Abstract

Introduction: Recurrent vasovagal syncope (VVS) is associated with decreased quality-of-life and frequent use of emergency services. The evidence base for causality, diagnostic procedures and potential VVS treatments is poor. Scattered observations in the literature suggest a link between respiratory disturbances during sleep and VVS. Empirical observations lead us to further hypothesise that the appropriate management of sleep apnoea syndrome (SAS) may help resolve comorbid recurrent VVS in certain patients. We therefore designed this pilot study to provide a framework for the observation of changes in outcomes accompanying the deployment of SAS treatments in patients with VVS.

Methods and analysis: This is a multicentre, registry-based study whose primary objective is to evaluate the effect of SAS management on the number of syncope/presyncope episodes in a population suffering from both VVS and SAS. To this effect, syncope rates prior to the treatment of SAS will be compared with those occurring after the initiation of the latter. In addition, yearly assessments will collect data for echocardiography, polysomnography, Holter monitoring, table tilt tests, multiple sleep latency tests, SAS management parameters and questionnaires describing fatigue, depression and quality-of-life. Sixty patients will be included with a minimum follow-up period of 12 months. The primary analysis will use comparisons of centrality for paired data to describe the changes in syncope rates before versus after the initiation of SAS management. Longitudinal data will be analysed using mixed models with patients set as a random effect. Subgroup analyses will be performed for SAS-treatment adherence and efficacy.

Ethics and dissemination: The VVS-SAS registry was approved by an ethics committee (Comité pour la Protection des Personnes Ile-de-France VI, Reference number CPP/2-18) in accordance with French law. The princeps publication will present before-after SAS management results and longitudinal analyses.

Trial registration number: NCT04294524. Pre-results.

Keywords: adult cardiology; adult thoracic medicine; sleep medicine.

Conflict of interest statement

Competing interests: VP declares personal fees (outside the submitted work) from Resmed, Lowenstein, Phillips and non-financial support (outside the submitted work) from SOS Oxygène and ISIS. FG reports personal fees (outside the submitted work) from Air Liquide Santé, Cidelec, Resmed, Sefam, and non-financial support (outside the submitted work) from Air Liquide Santé, Asten Santé, Sefam.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Rose MS, Koshman ML, Spreng S, et al. . The relationship between health-related quality of life and frequency of spells in patients with syncope. J Clin Epidemiol 2000;53:1209–16. 10.1016/S0895-4356(00)00257-2
    1. Giada F, Silvestri I, Rossillo A, et al. . Psychiatric profile, quality of life and risk of syncopal recurrence in patients with tilt-induced vasovagal syncope. Europace 2005;7:465–71. 10.1016/j.eupc.2005.05.008
    1. Peyrouse E, Franceschi F, Prévôt S, et al. . Prise en charge actuelle des syncopes - Standardisation de la démarche et unités spécialisées. Propos Cardiol 2012:33–9.
    1. Sun BC. Quality-Of-Life, health service use, and costs associated with syncope. Prog Cardiovasc Dis 2013;55:370–5. 10.1016/j.pcad.2012.10.009
    1. Puel V, Pepin JL, Gosse P. Sleep related breathing disorders and vasovagal syncope, a possible causal link? Int J Cardiol 2013;168:1666–7. 10.1016/j.ijcard.2013.03.061
    1. Sun BC, Emond JA, Camargo CA. Characteristics and admission patterns of patients presenting with syncope to U.S. emergency departments, 1992-2000. Acad Emerg Med 2004;11:S4–34. 10.1016/j.annemergmed.2004.07.016
    1. Glatter KA, Chiamvimonvat N, Whitcomb C, et al. . Images in cardiovascular medicine. Malignant vasovagal syncope. Circulation 2003;107:2987–8. 10.1161/01.CIR.0000068033.19278.F1
    1. Krediet CTP, Jardine DL, Cortelli P, et al. . Vasovagal syncope interrupting sleep? Heart 2004;90:e25. 10.1136/hrt.2003.031294
    1. Guilleminault C, Stoohs R, Clerk A, et al. . A cause of excessive daytime sleepiness. the upper airway resistance syndrome. Chest 1993;104:781–7. 10.1378/chest.104.3.781
    1. Cintra F, Poyares D, DO Amaral A, Amaral A DO, et al. . Heart rate variability during sleep in patients with vasovagal syncope. Pacing Clin Electrophysiol 2005;28:1310–6. 10.1111/j.1540-8159.2005.00272.x
    1. Smith ML, Niedermaier ON, Hardy SM, et al. . Role of hypoxemia in sleep apnea-induced sympathoexcitation. J Auton Nerv Syst 1996;56:184–90. 10.1016/0165-1838(95)00062-3
    1. Willis FB, Isley AL, Geda YE, et al. . Resolution of syncope with treatment of sleep apnea. J Am Board Fam Med 2008;21:466–8. 10.3122/jabfm.2008.05.070274
    1. Cohen J. A power primer. Psychol Bull 1992;112:155–9. 10.1037/0033-2909.112.1.155
    1. Faul F, Erdfelder E, Lang A-G, et al. . G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39:175–91. 10.3758/BF03193146
    1. Blanc J-J. Clinical laboratory testing: what is the role of tilt-table testing, active standing test, carotid massage, electrophysiological testing and ATP test in the syncope evaluation? Prog Cardiovasc Dis 2013;55:418–24. 10.1016/j.pcad.2012.11.002
    1. Perneger TV, Leplège A, Etter JF, et al. . Validation of a French-language version of the mos 36-Item short form health survey (SF-36) in young healthy adults. J Clin Epidemiol 1995;48:1051–60. 10.1016/0895-4356(94)00227-H
    1. Rose MS, Koshman M-L, Ritchie D, et al. . The development and preliminary validation of a scale measuring the impact of syncope on quality of life. Europace 2009;11:1369–74. 10.1093/europace/eup106
    1. Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness scale. Sleep 1991;14:540–5. 10.1093/sleep/14.6.540
    1. Koutsourelakis I, Perraki E, Economou NT, et al. . Predictors of residual sleepiness in adequately treated obstructive sleep apnoea patients. Eur Respir J 2009;34:687–93. 10.1183/09031936.00124708
    1. Pépin J-L, Viot-Blanc V, Escourrou P, et al. . Prevalence of residual excessive sleepiness in CPAP-treated sleep apnoea patients: the French multicentre study. Eur Respir J 2009;33:1062–7. 10.1183/09031936.00016808
    1. Cardenas J. Echelles et outils d’évaluation en médecine générale. Le Généraliste 2002.
    1. Pichot P, Brun JP. [Brief self-evaluation questionnaire for depressive, asthenic and anxious dimensions]. Ann Med Psychol 1984;142:862–5.
    1. Nelson W. Confidence limits for recurrence Data—Applied to cost or number of product repairs. Technometrics 1995;37:147–57.
    1. Nelson WB. Recurrent events data analysis for product repairs, disease recurrences, and other applications. SIAM, 2003.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner